Medical & Economical Evaluation of Fenestrated & Branched Stent-grafts to Treat Complex Aortic Aneurysms (Windows1)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Aortic Aneurysms

Treatments: Procedure: Open Surgical Repair; Device: Endovascular aortic repair with branched/fenestrated stent-graft

Study type: Observational

Funder types: Other

Identifiers

NCT01168037

IC090126

Details and patient eligibility

About

The aim of this study is to prospectively compare the perioperative mortality severe morbidity and the costs of endovascular versus conventional surgical repair of pararenal, supra-renal and type 4 THORACO-abdominal aortic aneurysms.

The primary goal of the study is to demonstrate a significant drop in 30-day mortality and life threatening morbidity in the endovascular arm of the study. Our hypothesis, derived from the literature, that the average 30-days mortality is 3% after endovascular repair and 10% after open surgery justifies the design of a prospective study between endovascular therapy (250 patients (amendment) treated in 8 University hospitals with significant experience of the technique) and open repair (660 similar patients analyzed form the national database of the MOH).

Full description

The aim of this study is to prospectively compare the perioperative mortality severe morbidity and the costs of endovascular versus conventional surgical repair of pararenal, supra-renal and type 4 THORACO-abdominal aortic aneurysms.

The primary goal of the study is to demonstrate a significant drop in 30-day mortality and life threatening morbidity in the endovascular arm of the study. Our hypothesis, derived from the literature, that the average 30-days mortality is 3% after endovascular repair and 10% after open surgery justifies the design of a prospective study between endovascular therapy (250 patients (amendment) treated in 8 University hospitals with significant experience of the technique) and open repair (660 similar patients analyzed form the national database of the MOH).

In-hospital morbidity are similarly expected to be lower in the endovascular group. We also wish to demonstrate that endovascular repair does not represent a significant over-cost, as compared to open repair. The cost of the implantable medical device (IMD), of follow-up screening, and of eventual repeated interventions should be compensated by a reduced stay in intensive care unit ICU, and by a reduced in-hospital length of stay.

Enrollment: 270 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

The following anatomical inclusion criteria must be met:

• Absence of significant angulations (< 60°) of aorta or of iliac arteries
• Absence of tight stenosis (>70%) of more than one target artery (renal or visceral artery to be perfused from the side holes of the stent-graft)
• Diameter of target arteries over 5 mm
• Iliac and femoral arteries allowing insertion of the delivery system (> 7 mm) or suitable for insertion of an access conduit

Exclusion criteria

• Limited expected life expectancy
• Emergency cases
• Refuse to participate to the study

Trial design

270 participants in 3 patient groups

Open repair

Description:

Open Surgical Repair (aortic replacement with revascularization of visceral arteries)

Treatment:

Procedure: Open Surgical Repair

Endovascular (Windows 1)

Description:

Endovascular therapy branched or fenestrated stent-graft

Treatment:

Device: Endovascular aortic repair with branched/fenestrated stent-graft

Endovascular (Windows 3)

Description:

Endovascular therapy branched or fenestrated stent-graft (vascutek anaconda)

Treatment:

Device: Endovascular aortic repair with branched/fenestrated stent-graft